FDA UDI
In Commercial Distribution
🇺🇸 United States
Luminance RED Cold Sore Device
DI: 00850063220064
·
Model: TN1927G
·
Luminance Medical Ventures Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Luminance RED Cold Sore Device
- Primary DI
- 00850063220064
- Version / Model
- TN1927G
- Company Name
- Luminance Medical Ventures Incorporated
- Labeler DUNS
- 065554288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-27
- Public Version
- 1
- Public Version Date
- 2026-02-04
- Public Version Status
- New
- Public Device Record Key
- f0afb6e1-9e7a-447f-874b-0d3d1da3a148
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKJ | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | General, Plastic Surgery | 878.4860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52750 | Infrared-light cold sore treatment device | A hand-held, battery-powered, portable device designed to be used by a layperson to emit infrared light intended as therapy to reduce the duration of cold sores caused by the herpes virus (herpes labialis). It typically consists of a self-contained unit, light-emitting diodes (LEDs), an internal microprocessor and software, activation control and signal light, and disposable batteries. Upon application, it emits infrared light (wavelengths around 1072 nm) to the dermis of the affected area of an erupting cold sore for a pre-set period of time (e.g., few minutes) and provides a signal to the user when the treatment is complete. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850063220064 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251973 | 000 |